Half-Year 2022 Financial and Clinical Trials Update
Roche
Enspryng (satralizumab, RG6168, SA237)
Anti-IL-6 receptor humanized monoclonal antibody
Indication
Generalised myasthenia gravis (MG)
Myelin oligodendrocyte glycoprotein antibody disease (MOGAD)
Phase/study
# of patients
Phase III
Luminesce
N=240
• ARM A: Enspryng plus standard of care
Design
Primary endpoint
Status
CT Identifier
•
ARM B: Placebo plus standard of care
■ Mean change from baseline in total MG-ADL score at week 24 in AChR+
population
Orphan Drug Designation granted in US Q1 2021
FPI Q4 2021
NCT04963270
Phase III
METEOROID
N=152
⚫ARM A: Enspryng at weeks 0, 2, 4 (loading doses) and maintenance doses
q4w
⚫ARM B: Placebo
■ Time from randomization to the first occurrence of a MOGAD relapse
■
FPI expected Q3 2022
Orphan Drug Designation granted by FDA in Q4 2021
In collaboration with Chugai
MG-ADL= Myasthenia Gravis Activities of Daily Living; AChR-Acetylcholine receptor; MOGAD-Myelin Oligodendrocyte Glycoprotein Antibody Disease
NCT05271409
112
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